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Evaluating the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)

Primary Purpose

Appendicitis Acute, Appendectomy

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Outpatient (OA)
Hospitalization appendectomy (HA)
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Appendicitis Acute

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 14 years of age and who provide informed consent to participate in the study.
  • Patients with non complicated acute appendicitis requiring and urgent appendectomy (laparoscopic or minimum incision)
  • Negative appendicectomy.

Exclusion Criteria:

  • Complicated acute appendicitis (abscess, perforated, necrosis and peritonitis)
  • Need to place intraoperative drainage.
  • Patients with American Society of Anesthesiologists (ASA) >IV.
  • Immunosuppressed patients.
  • Pregnant.
  • Possibility of inflammatory bowel disease.
  • No family support.
  • No informed consent signature.
  • Impossibility to comply with the established follow-up

Sites / Locations

  • Hospital Universitario Virgen Del RocioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Outpatient appendectomy

Hospitalization appendectomy

Arm Description

Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room without requiring hospital admission. The degree of satisfaction of the quality of the service and the care that must be completed before discharge and after surgery will be recorded. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.

Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room and then be admitted to hospital beds, to be discharged within approximately 12 hours. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.

Outcomes

Primary Outcome Measures

Rates of ambulatory appendectomy patients that have ambulatory surgery
Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery
Rates of readmission of appendectomy patients that had ambulatory surgery
Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery

Secondary Outcome Measures

Prevalence of ambulatory appendectomy patients
Measure the percentage of ambulatory surgery and uncomplicated acute appendicitis vs the percentage of ambulatory surgery in failure patients with the same pathology e.g. Uncontrolled abdominal pain with analgesia. Upper airway discomfort related to intubation that is not controlled with medication. Pain in the back or shoulders in relation to the pneumoperitoneum that are in patients with not controlled with the medication. Hemodynamically abnormal. Uncontrolled bleeding at the level of any of the wounds. Need for reoperation. Need to re-enter or consult the Emergency Service No spontaneous urination. Nausea / vomiting. Oral intolerance. No wandering. Insecurity or fear of the patient at discharge.
Media of time until the total incorporation to the activities of the daily life after appendectomy
To value the time until the total incorporation to the activities of the daily life after appendectomy.
Rates of satisfaction
Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire.
Costs of the outpatient regimen versus the hospitalization of patients
Compare the costs of the outpatient regimen versus the hospitalization of patients with uncomplicated acute appendicitis (cost-minimization analysis).

Full Information

First Posted
February 11, 2020
Last Updated
January 12, 2021
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT04464382
Brief Title
Evaluating the Safety and Efficacy of a Outpatient Appendectomy
Acronym
PENDI_CSI
Official Title
A Randomized Double-blind Clinical Trial to Evaluate the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 2019 (Actual)
Primary Completion Date
April 28, 2021 (Anticipated)
Study Completion Date
October 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the Safety and Efficacy of a outpatient appendectomy. Half of participants will be perform the hospitalization, while the other half will undergo the outpatient appendectomy
Detailed Description
Acute appendicitis (AA) is one of the most common causes of acute abdomen and one of the most frequent diagnoses that require urgent surgery worldwide. Many laparoscopic procedures are currently performed on an outpatient basis.Laparoscopic appendectomy, however, continues to require postoperative hospitalization averaging between 1 and 2 days, at most institutions. At present ambulatory laparoscopic appendectomy (LA) are gained popularity due to the improved understanding of patient selection criteria, the application of enhanced recovery pathways, and the potential for improving healthcare resource utilization. There are few studies about to compare the morbidity and readmission rates between ambulatory and conventional LA. There is a lack of high-quality comparative studies making conclusive recommendations not possible at this time. Based on current data, ambulatory LA may be safe and feasible as compared with conventional LA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute, Appendectomy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
291 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Outpatient appendectomy
Arm Type
Experimental
Arm Description
Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room without requiring hospital admission. The degree of satisfaction of the quality of the service and the care that must be completed before discharge and after surgery will be recorded. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.
Arm Title
Hospitalization appendectomy
Arm Type
Active Comparator
Arm Description
Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room and then be admitted to hospital beds, to be discharged within approximately 12 hours. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.
Intervention Type
Procedure
Intervention Name(s)
Outpatient (OA)
Intervention Description
Patients who are candidates for OA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision. Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the OA group (case group), he will be discharged on an outpatient basis from the post-surgical stay unit without requiring hospital admission.
Intervention Type
Procedure
Intervention Name(s)
Hospitalization appendectomy (HA)
Intervention Description
Patients who are candidates for HA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision. Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the case group (HA), he will be admitted in hospital beds.
Primary Outcome Measure Information:
Title
Rates of ambulatory appendectomy patients that have ambulatory surgery
Description
Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery
Time Frame
20 months
Title
Rates of readmission of appendectomy patients that had ambulatory surgery
Description
Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Prevalence of ambulatory appendectomy patients
Description
Measure the percentage of ambulatory surgery and uncomplicated acute appendicitis vs the percentage of ambulatory surgery in failure patients with the same pathology e.g. Uncontrolled abdominal pain with analgesia. Upper airway discomfort related to intubation that is not controlled with medication. Pain in the back or shoulders in relation to the pneumoperitoneum that are in patients with not controlled with the medication. Hemodynamically abnormal. Uncontrolled bleeding at the level of any of the wounds. Need for reoperation. Need to re-enter or consult the Emergency Service No spontaneous urination. Nausea / vomiting. Oral intolerance. No wandering. Insecurity or fear of the patient at discharge.
Time Frame
20 months
Title
Media of time until the total incorporation to the activities of the daily life after appendectomy
Description
To value the time until the total incorporation to the activities of the daily life after appendectomy.
Time Frame
20 months
Title
Rates of satisfaction
Description
Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire.
Time Frame
20 months
Title
Costs of the outpatient regimen versus the hospitalization of patients
Description
Compare the costs of the outpatient regimen versus the hospitalization of patients with uncomplicated acute appendicitis (cost-minimization analysis).
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 14 years of age and who provide informed consent to participate in the study. Patients with non complicated acute appendicitis requiring and urgent appendectomy (laparoscopic or minimum incision) Negative appendicectomy. Exclusion Criteria: Complicated acute appendicitis (abscess, perforated, necrosis and peritonitis) Need to place intraoperative drainage. Patients with American Society of Anesthesiologists (ASA) >IV. Immunosuppressed patients. Pregnant. Possibility of inflammatory bowel disease. No family support. No informed consent signature. Impossibility to comply with the established follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pareja C Felipe, PhD
Phone
+34630962443
Email
felipe.pareja67@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Durán MC Virginia María, MD
Phone
+34630962443
Email
virginia.dm.87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pareja C Felipe, PhD
Organizational Affiliation
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Padillo R Javier, PhD
Organizational Affiliation
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Durán MC Virginia María, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pareja C Felipe, PhD
Phone
+34630962443
Email
felipe.pareja67@gmail.com
First Name & Middle Initial & Last Name & Degree
Durán MC Virginia, MD
Phone
+34620073024
Email
virginia.dm.87@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27437029
Citation
Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
Results Reference
background
PubMed Identifier
22609030
Citation
Cash CL, Frazee RC, Abernathy SW, Childs EW, Davis ML, Hendricks JC, Smith RW. A prospective treatment protocol for outpatient laparoscopic appendectomy for acute appendicitis. J Am Coll Surg. 2012 Jul;215(1):101-5; discussion 105-6. doi: 10.1016/j.jamcollsurg.2012.02.024. Epub 2012 May 19.
Results Reference
background
PubMed Identifier
24725679
Citation
Aguayo P, Alemayehu H, Desai AA, Fraser JD, St Peter SD. Initial experience with same day discharge after laparoscopic appendectomy for nonperforated appendicitis. J Surg Res. 2014 Jul;190(1):93-7. doi: 10.1016/j.jss.2014.03.012. Epub 2014 Mar 12.
Results Reference
background
PubMed Identifier
26920990
Citation
Frazee RC, Abernathy SW, Isbell CL, Isbell T, Regner JL, Smith RD. Outpatient Laparoscopic Appendectomy: Is It Time to End the Discussion? J Am Coll Surg. 2016 Apr;222(4):473-7. doi: 10.1016/j.jamcollsurg.2015.12.053. Epub 2016 Jan 14.
Results Reference
background
PubMed Identifier
29079020
Citation
Frazee R, Burlew CC, Regner J, McIntyre R, Peltz E, Cribari C, Dunn J, Butler L, Reckard P, Dissanaike S, Karimi K, Behnfield C, Melo N, Margulies D. Discussion of: "Outpatient laparoscopic appendectomy can be successfully performed for uncomplicated appendicitis: A Southwestern Surgical Congress multicenter trial". Am J Surg. 2017 Dec;214(6):1010-1011. doi: 10.1016/j.amjsurg.2017.10.003. Epub 2017 Oct 5. No abstract available.
Results Reference
background
PubMed Identifier
31273450
Citation
Trejo-Avila M, Cardenas-Lailson E, Valenzuela-Salazar C, Herrera-Esquivel J, Moreno-Portillo M. Ambulatory versus conventional laparoscopic appendectomy: a systematic review and meta-analysis. Int J Colorectal Dis. 2019 Aug;34(8):1359-1368. doi: 10.1007/s00384-019-03341-y. Epub 2019 Jul 5.
Results Reference
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Evaluating the Safety and Efficacy of a Outpatient Appendectomy

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